Director Data Management (m/f/d) Eysins

  • Fresenius Kabi
  • Eysins, VD, Switzerland
  • 07/05/2022
Full time Data Engineering Big Data Data Management Biostatistics

Job Description

Job details

Job Type

Full Job Description

With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

Your assignments

Functional Goal:

Provision of data management expertise from study design to submission to Regulatory Authorities. On behalf of Fresenius-Kabi SwissBioSim, lead oversight of data management activities outsourced to external partners. Provide support to but not limited to CRO selection, GxP adherence, Inspection readiness, Protocols, SAPs and other relevant clinical study documents. Accountability for Data Management KPIs.

Main Tasks:

  • Strong technical expertise to ensure completeness, correctness and consistency of clinical and non clinical data in all studies/programs to achieve results in agreement with defined quality specifications and timelines
  • Manage and troubleshoot operational challenges and GCP compliance
  • Promote standardization in collaboration with Biostatistics and other colleagues to improve consistency across all programs.
  • Track emerging trends and apply them to improve data management support across all programs.
  • Lead the development of CRFs/eCRFs, edit checks, reconciliation plans, data communication plans, data transfers, SDTM packages and routine reports to track data collection/quality progress
  • Contribute to the development of electronic submission packages
  • Review of clinical study protocols and SAPs/mock TLFs. Provide input for high level forecasting of timelines for data management tasks and estimation of resources and budget
  • Subject Matter Expert for audits and inspections
  • Participate in the selection process of CROs and provide oversight of outsourced activities
  • Collaborate effectively with cross-functional teams and external partners.
  • Develop, review, update, and add SOPs as company/situations evolve when applicable

Other Tasks:

  • Provide timely feedback and solutions to management regarding staffing needs and individual performance.
  • Recruit new staff, onboard and manage new employees as needed.
  • Interact proactively and solution orientated with other clinical and non clinical functions

Your profile

  • Master’s degree (or equivalent)
  • 10+ years of related industry experience within the functional area
  • Experience with web based Electronic Data Capture and data management systems
  • Experience with CRO oversight
  • Knowledge of SAS (basic use)
  • Experienced knowledge of CDISC (SDTM format)
  • Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective.
  • Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)
  • Strong communication skills; verbal, written, and presentation
  • Highly motivated and enjoys working in a fast-paced environment
  • Strong organizational skills and the ability to prioritize and multi-task
  • Positive, flexible self-starter who thrives under pressure

Eysins, Switzerland

Working Rate:

Full-time (100%)

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